Study to Test Efficacy of Real-time Reminders on Apple Watch To Decrease Late or Missed Meal Boluses

Completed · Not applicable

Conditions studied: Diabetes Mellitus, Type 1

In brief

This will be a randomized, cross-over, unblinded study with subjects randomized upon entry into the study to either begin using the Klue software for 6 weeks or to continue with their usual care for 6 weeks. Subjects are eligible for enrollment if they are using a continuous glucose monitor (CGM) with an insulin pump or an insulin pen with memory, and are missing or late in giving at least 4 food boluses in the previous two weeks. Missing or late meal boluses will be assessed through their pump/pen and sensor downloads. This is a pilot study. There is no preliminary data to do a true power calculation. The primary outcome will be the change in the number of missed meal boluses in the two weeks prior to each visit. Secondary outcome measures will be the number of missed meal boluses in each month of the study, change in HbA1c levels (measured every 6 weeks), accuracy of the Klue software in detecting meals (true positive and false positive rates), and a user satisfaction survey.

Key facts

Study ID

NCT03809858

Run by

University of Virginia

People needed

12

Starts

2019-05-29

Expected to finish

2019-11-18

Last updated by the study team

2020-04-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18 and over
• Using an insulin pump for at least 3 months and currently using CGM or using an insulin pen with memory and currently using a CGM
• Willing to wear a CGM at least 70% of the time while in the study
• Willing to wear an Apple watch on their dominant hand while awake
• Missing or late in giving at least four food boluses in the previous 2 weeks
• Understanding and willingness to follow the protocol and sign informed consent

You may not qualify if…

• Pregnant or lactating women
• A known medical condition that in the judgement of the investigator might interfere with the completion of the protocol Note: Adequately treated thyroid disease and celiac disease do not exclude subjects from enrollment.
• Current treatment for a seizure disorder
• Inpatient psychiatric treatment in the past 6 months
• Subject may participate in another trial if it is approved by the investigators of both trials.

Where it is running

• University of Virginia — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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